吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂稳定性的研究

Studies on the Stability of Adsorbed Purified Pertussis-Diphtheria-Tetanus Combined Vaccine

将连续生产并已申报人体接种反应观察的三批吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂，分别于４～８℃、１８～２２℃、３７℃贮存半年、１年、１年半和３０天，然后以小鼠法或豚鼠法对该制剂进行安全稳定性、效力稳定性以及毒性逆转等测试。其毒力安全稳定性试验表明，三批混合制剂中的精制百日咳菌苗在４～８℃贮半年、１年、１年半后、它们的ＢＷＤＵ／ｍｌ、ＬＰＵ／ｍｌ、ＨＳＵ／ｍｌ均无显著性差异（Ｐ＞０．０５）；白喉及破伤风类毒素在４～８℃贮存半年，１年、１年半以及１８～２２℃贮存半年和３７℃贮存３０天后，三批测试组的豚鼠均健存且体重增加。在效力稳定性试验中，４～８℃贮存１年和１年半后精制百日咳菌苗的效力与贮存前（分别为２６．７３ＩＵ／ｍｌ、２１．０２ＩＵ／ｍｌ、１９．１７ＩＵ／ｍｌ）无显著性差异（ｔ＝０．１１４；Ｐ＞０．０５）；白喉及破伤风类毒素４～８℃贮存长达１年半后，效力仍在２～３．２ＩＵ／ｍｌ，动物保护率仍可达８０～１００％。三批混合制剂在３７℃贮存３０天后，通过Ｓｃｈｉｃｋ毒性试验及测定ＢＷＤＵ／ｍｌ、ＬＰＵ／ｍｌ、ＨＳＵ／ｍｌ各指标显示，精制百日咳菌苗、白喉和破伤风类毒素无毒性逆转。说明该吸附精制百、白。

The stability of adsorbed purified pertussis-diphtheria-tetanus combined vaccine stored at different temperature was investigated. Results showed that the APDT combined vaccine at 4-8℃ for 0.5,1 and 1.5 years. 37℃ for 30 days, 18-22℃ for 0.5 year compared with before and after storing, the toxicity and potency unit has no significant difference (P＞0.05), The toxic reversion test of the purified pertussis vaccine and the purified diphtheria toxoid has also no significant difference before and after storing.